[Federal Register Volume 64, Number 180 (Friday, September 17, 1999)]
[Rules and Regulations]
[Pages 50445-50448]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-24235]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 101
[Docket No. 98P-0968]
Food Labeling: Declaration of Ingredients
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending its
ingredient labeling regulations to permit the use of ``and/or''
labeling for the various fish species used in the production of certain
processed seafood products, i.e., surimi and surimi-containing foods.
This action responds to a petition submitted by the National Fisheries
Institute (NFI) requesting more flexible ingredient labeling for the
fish ingredients used in the production of surimi products. This rule
will permit manufacturers of surimi and surimi-containing products to
maintain a single label inventory identifying all of the fish species
that are used in the manufacture of these products.
DATES: This rule is effective on September 17, 1999.
FOR FURTHER INFORMATION CONTACT: Linda J. McCollum, Center for Food
Safety and Applied Nutrition (HFS-158), Food and Drug Administration,
200 C St. SW., Washington, DC 20204, 202-205-5099.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of April 9, 1999 (64 FR 17295), FDA
published a proposal to amend the ingredient labeling regulations
(hereinafter referred to as the April 9 proposal) to permit the use of
``and/or'' labeling for the various fish species used in the production
of certain processed seafood products such as surimi and surimi-
containing foods. The April 9 proposal responded to a citizen's
petition submitted by NFI, which requested that FDA allow more flexible
ingredient labeling for the fish ingredients used as a component in
surimi production. NFI asserted that the use of ``and/or'' labeling
would have two advantages: (1) Reduce the economic burden on
manufacturers of having to maintain extensive label inventories to
account for all possible fish species or predominance combinations used
and (2) enable manufacturers to effectively manage harvestable
resources by allowing them to take advantage of the varying species and
quantities of fish available at different times of the year. The
petitioner also asserted that because the fish ingredients are
thoroughly decharacterized during processing, the specific fish species
used does not influence the nutritional content or product character,
nor does it influence consumer-purchasing decisions.
In regard to the fish ingredients used to produce surimi, the NFI
petition described them as refined myofibrillar protein products. The
processing of the fish ingredients is such that the fish, regardless of
species, are headed, gutted, filleted, skinned, deboned, and minced.
The minced flesh is then washed and screened to decharacterize the
tissue by removing blood, fat, pigments, and enzymes characteristic of
the fish species, resulting in a slurry not recognizable as fish flesh.
The fish ingredient used as a component of surimi is a washed,
dehydrated slurry devoid of color, odor, texture, and taste. Surimi, an
intermediate processed seafood product, is made by mixing
cryoprotectants into the myofibrillar protein base then extruding it.
It can be used fresh or stored frozen until processed further into
seafood analog food products (Ref. 1).
Based on FDA's review of the information provided in the petition,
and other information available to the agency describing the production
of surimi, we tentatively found in the April 9 proposal that the use of
``and/or'' ingredient labeling for the declaration of the fish species
in certain processed seafood products is consistent with other
exceptions to the ingredient labeling requirements providing for ``and/
or'' labeling. The agency also tentatively found that such labeling
would not compromise the type or amount of information received by the
consumer regarding surimi and surimi-containing foods. Consequently, in
the April 9 proposal, FDA proposed to amend its ingredient labeling
regulations to permit the use of ``and/or'' labeling for the fish
ingredient present in surimi and surimi-containing foods. Specifically,
the agency proposed that when processed seafood products contain fish
protein ingredients consisting primarily of the myofibrillar protein
fractions from one or more fish species and the manufacturer is unable
[[Page 50446]]
to adhere to a constant pattern of fish species in the fish protein
ingredient, because of seasonal or other limitations of species
availability, the common or usual name of each individual fish species
need not be listed in descending order of predominance. Fish species
not present in the fish protein ingredient may be listed if they are
sometimes used in the product. Such ingredients must be identified by
words indicating that they may not be present, such as ``or,'' ``and/
or,'' or ``contains one or more of the following:'' e.g., ``fish
protein (contains one or more of the following: Pollock, cod, and/or
pacific whiting).'' Interested persons were given until June 23, 1999,
to comment on the April 9 proposal.
II. Comments and Agency Response
In response to the April 9 proposal, FDA received 16 letters, each
containing 1 or more comments. The comments were from government,
industry, industry trade associations, academia, and consumer
organizations. All of the comments agreed with the agency's decision to
amend the ingredient labeling regulations in 21 CFR 101.4(b)
(Sec. 101.4(b)) to permit the use of ``and/or'' labeling for the
various fish species used in the production of surimi and surimi-
containing foods.
1. Several comments requested that FDA immediately issue a letter
advising manufacturers that the agency would use its enforcement
discretion and permit ``and/or'' labeling consistent with the proposed
rule until a final rule is published. The comments asserted that such
action would provide relief from onerous labeling requirements. The
agency did not act on the request for enforcement discretion because of
the short timeframe in which it intended to publish the final rule. The
agency considered it a more efficient use of its resources to
concentrate on completing the final rule in accordance with Congress'
intent that the agency publish the final rule within 1 year of
receiving the petition. FDA, in publishing this final rule within that
timeframe, has met congressional intent. Further, this final rule is
effective on the date of publication in the Federal Register;
therefore, the comment is moot.
2. A few comments suggested revising the ingredient statement so
that all possible species of fish that can be used for the fish
ingredient of surimi and surimi-containing foods would be included in
the ingredient statement. They proposed that this be done by either
leaving a blank for other species names or adding ``may'' to the
``contains... and/or'' statement.
The agency does not agree with this suggestion. The agency
believes there is an intrinsic difference between the phrase ``may
contain,'' with the inherent suggestion that the food may or may not
contain the named species, and the phrase ``contains * * * and/or.''
FDA believes that the statement that a food may contain a particular
fish species would be useless to consumers because the statement would
not advise them whether the product would ever contain the fish species
named. On the other hand, ``and/or'' labeling informs the consumer that
one or more of the fish species declared is sometimes present in the
product. Therefore, the agency is not granting the request to allow the
use of the term ``may contain'' in the declaration of fish species in
fish protein. The language of the final rule provides for the inclusion
of any species of fish that is sometimes used in the surimi or surimi-
containing product and is consistent with all other regulations in
Sec. 101.4(b) where the use of ``and/or'' labeling is allowed.
3. Some comments disagreed with the use of the term ``fish
protein'' as an appropriate common or usual name in the ingredient
list. Several comments questioned whether FDA used the term ``fish
protein'' as an example and did not intend to preclude the use of other
terms. They requested that FDA clarify that the term ``fish protein''
was just an example of an acceptable term for the fish ingredient. The
comments asserted that other terms such as ``fish'' or ``fish blend''
rather than ``fish protein'' would be better for both industry and
consumers as the descriptive name, noting that other countries use
these names for labeling this ingredient.
Another comment stated that ``fish protein'' would be an
inappropriate and confusing term for consumers. The comment contended
that consumers would equate ``fish protein'' with denatured fish
protein concentrate that is used in fish fertilizer or in animal feed.
The term ``fish protein,'' as used in the context of this
regulation, is a collective (generic) name to describe the fish
ingredient. FDA believes that the use of ``fish'' or ``fish blend'' is
not an appropriately descriptive collective name, as it does not
sufficiently describe the basic nature of the food ingredient.
According to the petition, the ingredient used in surimi is processed
fish muscle tissue that has been totally decharacterized by being
defatted, decolorized, deflavorized, deodorized, and mechanically
detexturized. Consequently, the basic nature of the food is no longer
``fish'' as is commonly understood by consumers. The term ``fish'' or
``fish blend'' implies the use of the natural fish flesh in the
product; whereas, the organoleptic properties and nutritional values of
the fish in surimi products are significantly modified. Further, the
agency accepted industry's position that ``and/or'' labeling was
appropriate for the fish protein ingredient because the species from
which the fish protein is derived are no longer distinguishable (64 FR
17295 at 17297).
In response to the comment regarding consumer perception, FDA is
not persuaded that consumers will confuse ``fish protein'' with
ingredients used in fertilizer or animal feed. The comment did not
provide data or other evidence supporting the contention that consumer
confusion would occur. Further, even though other human food
ingredients, such as liver or chicken, are declared on pet food labels
FDA is unaware of complaints or inquiries based on confusion of the
suitability of the ingredients.
Therefore, having considered the suggestions in these comments,
the agency concludes that the most appropriate collective term is
``fish protein.'' In the absence of an appropriate alternative
collective term the agency disagrees with the comments that requested
the agency to clarify that ``fish protein'' was intended to be only an
example of an acceptable ingredient name. At this time, ``fish
protein'' is the collective name that should be used to designate the
fish ingredient in surimi. The agency has modified the language in the
final rule to clarify this point. We recognize, however, that there
might be other terms that could appropriately describe the fish
ingredient. Thus, we are willing to consider the appropriateness of
other terms on a case-by-case basis as submitted in a citizen's
petition.
4. One comment that supported use of the term ``fish'' as an
appropriate descriptive name also suggested that the ingredient
statement of surimi include percentage designations as follows: ``Fish
(may contain one or more of the following: Pollock * * *) 50%, water
30% and other ingredients 20%.''
FDA believes that an ingredient statement is sufficiently
informative when it lists the ingredients in order of predominance by
weight. However, voluntary percentage declaration of ingredients is
provided for in Sec. 101.4(e). Furthermore, based on the arguments
presented in the petition, the agency questions the practicability of
percent ingredient labeling for these products because of its potential
to negate the usefulness of the ``and/or'' labeling format by requiring
a different label for
[[Page 50447]]
each different recipe of the surimi product. Therefore, the agency
concludes that it is neither necessary nor appropriate to amend the
regulations as suggested by the comment.
5. One comment requested that FDA broaden the scope of the
proposal to allow for the use of ``and/or'' ingredient labeling for
other fish ingredient products that may not meet the technical
description of surimi. This comment requested that minced fish
ingredients used in products such as fish sticks and portions that
conform to 21 CFR 102.45 (Sec. 102.45) and fish ingredients for stews,
soups, and chowders also be included in this rule. The comment
contended that these products rely on substantially the same fish
species used in surimi and, therefore, are subject to the same
seasonality, quota limitations, and labeling costs as surimi. Further,
the comment argued that processing of these types of ingredients
decharacterizes the fish species ``to an extent'' and the final product
may be made from a blend of several fish species.
FDA is not persuaded by the comment that it should broaden the
scope of this regulation to provide for ``and/or'' labeling to other
forms of fish ingredients such as minced fish. Surimi is a unique
product unrecognizable as fish due to its extensive processing. Because
the washed, blended minced fish and similar types of ingredients used
in making fish sticks and the other products mentioned in the comment
still retain taste and texture characteristic of the fish species used,
we believe it is inappropriate to include them under this regulation.
Fish sticks and portions made from minced fish are appropriately
labeled under Sec. 102.45.
III. Analysis of Economic Impacts
A. Benefit-Cost Analysis
FDA has examined the impacts of this rule under Executive Order
12866. Executive Order 12866 directs Federal agencies to assess all
costs and benefits of available regulatory alternatives and, when
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety, and other advantages, distributive impacts, and
equity). According to Executive Order 12866, a regulatory action is
``significant'' if it meets any one of a number of specified
conditions, including having an annual effect on the economy of $100
million; adversely affecting in a material way a sector of the economy,
competition, or jobs; or if it raises novel legal or policy issues. FDA
finds that this rule is not a significant regulatory action as defined
by Executive Order 12866. In addition, it has been determined that this
rule is not a major rule for the purpose of congressional review. For
the purpose of congressional review, a major rule is one which is
likely to cause an annual effect on the economy of $100 million; a
major increase in costs or prices; significant effects on competition,
employment, productivity, or innovation; or significant effects on the
ability of U.S.-based enterprises to compete with foreign-based
enterprises in domestic or export markets.
FDA agrees with the petitioner that the current combination of
seasonal species harvests, harvesting limits, labeling regulations, and
limited product storage times places an unwarranted and costly
logistical burden on surimi manufacturers. This combination of
circumstances forces surimi manufacturers to maintain and coordinate
several inventories of species-specific surimi and contingent labels
that declare the specific fish species used to make the surimi. The
convergence of these conditions also hampers the seafood industry's
efforts to use conventional and innovative surimi processing
technologies to optimize fishery yield.
This rule will mitigate the logistical burden faced by surimi
manufacturers. Because surimi manufacturers will be able to maintain a
single label inventory and use innovative technologies, they will be
able to operate more efficiently. Because of lower production costs,
consumers may see slightly lower prices for surimi. Because of the
greater flexibility for species usage, the goals of fisheries
management will be easier to achieve.
This rule will not result in any increase in societal costs.
Because the rule is permissive, there are no costs imposed on
producers. Because the new labels adequately inform consumers there
will be no costs to them in terms of lost information or increased
search costs. FDA received no comments to the April 9 proposal
concerning its analysis of economic impacts.
B. Small Entity Analysis
FDA has examined the impacts of this rule under the Regulatory
Flexibility Act (RFA). The RFA (5 U.S.C. 601-612) requires Federal
agencies to consider alternatives that would minimize the economic
impact of their regulations on small businesses and other small
entities. In compliance with the RFA, FDA finds that this rule will not
have a significant impact on a substantial number of small entities.
No costs will be generated by this final rule because it will not
require any labels to be changed, or any product to be reformulated.
Therefore, small businesses will only relabel or reformulate products
if the benefits of ``and/or'' labeling outweigh the costs. Accordingly,
under the RFA (5 U.S.C. 601-612), the agency certifies that this rule
will not have a significant economic impact on a substantial number of
small entities.
C. Unfunded Mandates Reform Act of 1995
FDA has examined the impacts of this rule under the Unfunded
Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). This rule does
not trigger the requirement for a written statement under section
202(a) of the UMRA because it does not impose a mandate that results in
an expenditure of $100 million (adjusted annually for inflation) or
more by State, local, and tribal governments in the aggregate, or by
the private sector, in any one year.
IV. Environmental Impact
The agency has previously considered the environmental effects of
this rule as announced in the proposed rule (68 FR 17295 at 17298). No
new information or comments have been received that would affect the
agency's previous determination that there is no significant impact on
the human environment and that neither an environmental assessment nor
an environmental impact statement is required.
V. Paperwork Reduction Act of 1995
This rule contains ingredient declaration provisions that fall
within the scope of the Paperwork Reduction Act of 1995 (44 U.S.C.
3501-3520). In the April 9 proposal the agency tentatively concluded
that the proposed provisions for the declaration of fish ingredients
using ``and/or'' labeling would not impose any new information
collection requirements. We did not receive any comments on this issue.
Therefore, the agency concludes that the provisions set forth below for
the declaration of fish ingredients using ``and/or'' labeling do not
impose any new information collection requirements because they create
an exception from existing ingredient declaration requirements to make
compliance easier. The ingredient declaration burden under
Sec. 101.4(b) has been approved by the Office of Management and Budget
(OMB control number 0910-0381).
[[Page 50448]]
VI. References
The following reference has been placed on display at the Dockets
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
1. Lee, C. M., ``Surimi Process Technology,'' Food Technology,
pp. 69 to 80, 1984.
List of Subjects in 21 CFR Part 101
Food labeling, Nutrition, Reporting and recordkeeping
requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act and
under authority delegated to the Commissioner of Food and Drugs, 21 CFR
part 101 is amended as follows:
PART 101--FOOD LABELING
1. The authority citation for 21 CFR part 101 continues to read as
follows:
Authority: 15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 342,
343, 348, 371.
2. Section 101.4 is amended by adding paragraph (b)(23) to read as
follows:
Sec. 101.4 Food; designation of ingredients.
* * * * *
(b) * * *
(23) When processed seafood products contain fish protein
ingredients consisting primarily of the myofibrillar protein fraction
from one or more fish species and the manufacturer is unable to adhere
to a constant pattern of fish species in the fish protein ingredient,
because of seasonal or other limitations of species availability, the
common or usual name of each individual fish species need not be listed
in descending order of predominance. Fish species not present in the
fish protein ingredient may be listed if they are sometimes used in the
product. Such ingredients must be identified by words indicating that
they may not be present, such as ``or'', ``and/or'', or ``contains one
or more of the following:'' Fish protein ingredients may be declared in
the ingredient statement by stating the specific common or usual name
of each fish species that may be present in parentheses following the
collective name ``fish protein'', e.g., ``fish protein (contains one or
more of the following: Pollock, cod, and/or pacific whiting)''.
* * * * *
Dated: September 13, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 99-24235 Filed 9-16-99; 8:45 am]
BILLING CODE 4160-01-F